Circular surgical fastening devices with tissue acquisition arrangements

ABSTRACT

A surgical instrument comprising an elongate shaft assembly operably supporting a circular surgical staple cartridge in a distal end thereof and a plurality of arcuate tissue acquisition members pivotally attached to the elongate shaft assembly and configured to be selectively radially deployable from a first position wherein the plurality of arcuate tissue acquisition members cooperate to form a continuous ring defining a continuous outer ring diameter and a second deployed position wherein each arcuate tissue acquisition member extends radially outward from the elongate shaft assembly is disclosed. The surgical instrument further comprises means for selectively deploying the plurality of arcuate tissue acquisition members between the first position and the second deployed position, a tissue cutting member comprising two diametrically opposed ends forming a plurality of tissue cutting edges, and means for selectively rotating the tissue cutting member relative to the plurality of arcuate tissue acquisition members.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 14/299,713, entitledTISSUE ACQUISITION ARRANGEMENTS AND METHODS FOR SURGICAL STAPLINGDEVICES, filed Jun. 9, 2014, which issued on Mar. 21, 2017 as U.S. Pat.No. 9,597,075, which is a divisional application claiming priority under35 U.S.C. § 121 to U.S. patent application Ser. No. 12/846,964, entitledTISSUE ACQUISITION ARRANGEMENTS AND METHODS FOR SURGICAL STAPLINGDEVICES, filed Jul. 30, 2010, which issued on Jul. 22, 2014 as U.S. Pat.No. 8,783,543, the entire disclosures of which are hereby incorporatedby reference herein.

FIELD OF THE INVENTION

The present invention generally relates to surgical staplers, and moreparticularly, to devices and methods for holding and/or protectingtissue adjacent to the stapler head of a circular stapler.

BACKGROUND

In certain types of surgical procedures, the use of surgical staples hasbecome the preferred method of joining tissue and, as such, speciallyconfigured surgical staplers have been developed for these applications.For example, intra-luminal or circular staplers have been developed foruse in surgical procedures involving the lower colon wherein sections ofthe lower colon are joined together after a diseased portion has beenexcised. Circular staplers useful for performing such procedures aredisclosed, for example, in U.S. Pat. Nos. 5,104,025; 5,205,459;5,285,945; and 5,309,927 which are each herein incorporated by referencein their respective entireties.

In general, a conventional circular stapler typically consists of anelongated shaft that has a proximal actuating mechanism and a distalstapler head mounted to the elongated shaft. The distal stapler headcommonly consists of a fixed stapling cartridge that contains aplurality of staples configured in a concentric circular array. A roundcutting knife is concentrically mounted in the cartridge interior to thestaples for axial travel therein. Extending axially from the center ofthe cartridge is a movable trocar shaft that is adapted to have a stapleanvil removably coupled thereto. The anvil is configured to form theends of the staples as they are driven into it. The distance between adistal face of the staple cartridge and the staple anvil is commonlycontrolled by an adjustment mechanism that is mounted to the proximalend of the stapler shaft for controlling the axial movement of thetrocar. Tissue that is clamped between the staple cartridge and thestaple anvil is simultaneously stapled and cut when the actuatingmechanism is activated by the surgeon.

When performing a lower colon procedure using a circular stapler, aportion of the intestine may be laparoscopically stapled using aconventional surgical stapler that is inserted through a trocar. Theconventional surgical stapler serves to place multiple rows of stapleson either side of the diseased portion of colon to be removed. Thetarget or diseased section is simultaneously cut as the adjoining end ofthe colon is stapled. After removing the diseased portion, the surgeontypically inserts the anvil of the circular stapling instrument into thedistal end of the lumen, distal of the staple line. This may be done byinserting the anvil head into an entry port cut into the distal lumen bythe surgeon. The lower staple line is utilized to hold the tissue of thecolon over the circular cartridge. This method seals both ends of thecolon only to have the sealed portions cut through and removed. Theseintermediate step staple lines are only temporary and facilitate thenext step in the procedure.

On occasion, the anvil can be placed transanally, by placing the anvilhead on the distal end of the stapler and inserting the instrumentthrough the rectum. Once the anvil has been installed in the distalportion of the intestine, the intestine is secured around the anvilshaft by what is known as a “purse string” suture. The proximal portionof intestine is similarly secured around the stapler head by a pursestring suture.

Once the ends of the intestine have been secured around their respectivecomponents, the surgeon, through an appropriate trocar sleeve, mayemploy a grasping device to grasp the anvil shaft and attach it to theportion of the trocar protruding within the stapler head. The surgeonthen closes the gap between the anvil and cartridge, thereby clampingthe proximal and distal ends of the intestine in the gap. The surgeonnext actuates the stapler causing several rows of staples to be driventhrough both ends of the intestine and formed, thereby joining the endsand forming a tubular pathway. Simultaneously, as the staples are drivenand formed, the concentric annular knife blade is driven through theintestinal tissue ends, cutting the ends adjacent to the inner row ofstaples. The surgeon then withdraws the stapler from the intestine andthe procedure is complete.

Such procedures and devices require the surgeon to install two pursestring sutures which lengthens the time required to complete thesurgical procedure. In addition, such procedures may at times causetissue “bunching” during the tissue cutting/stapling process.

Various attempts have been made to retain colon and other tissues aroundthe stapling device. For example, U.S. Pat. Nos. 5,309,927; 6,117,148;and 7,094,247 disclose various arrangements that, in general, employfasteners, ligation members, rings, springs, etc. that are apart fromthe stapling device itself in an effort to retain the tissue inposition. U.S. Pat. No. 5,669,918 discloses a mechanism that employs agrasper like arm to frictionally pin the tissue against the trocarshank. While such device is essentially self contained, the grasper armsmay ultimately be unable to effectively retain the tissue in position inpractice.

Thus, the need exists for devices and methods for reducing the timerequired to complete the surgical procedure as well as addressing othershortcomings and challenges associated with retaining tissue in positionwhen employing circular stapler arrangements.

The foregoing discussion is intended only to illustrate some of theshortcomings present in the field of the invention at the time, andshould not be taken as a disavowal of claim scope.

SUMMARY

In connection with a general aspect of various embodiments of thepresent invention, there is provided a surgical instrument thatcomprises an elongated shaft that defines a central axis and has adistal end portion that is configured to operably support a circularstaple cartridge therein. A tissue acquisition shaft is rotatablysupported within the elongated shaft and has a distal portion thatprotrudes distally beyond the distal end portion of the elongated shaft.At least one tissue acquisition member is pivotally attached to thedistal end portion of the tissue acquisition shaft such that the atleast one tissue acquisition member is selectively pivotable about acorresponding acquisition axis that is substantially parallel to thecentral axis from a retracted position to deployed positions uponapplication of a deployment motion thereto.

In connection with another general aspect of various embodiments of theinvention, there is provided a surgical instrument that comprises anelongated shaft that defines a central axis and terminates in a staplerhead. In various embodiments, the stapler head comprises a circularstaple cartridge that has a fastener face. The stapler head alsocomprises an axially movable cutting member. The surgical instrumentfurther comprises a firing member that is operably supported in theelongated shaft and oriented to apply a firing motion to the circularstaple cartridge. An anvil shaft assembly is operably supported withinthe elongated shaft and is configured to receive actuation motions fromthe handle assembly to cause the anvil shaft assembly to move axiallywithin the elongated shaft such that a distal connection portion thereofmoves axially relative to the fastener face. An anvil is removablyattachable to the distal connection portion of the anvil shaft assembly.A tissue acquisition shaft is rotatably supported within the elongatedshaft. A plurality of tissue acquisition members is pivotally attachedto a distal end portion of the tissue acquisition shaft. The pluralityof tissue acquisition members is selectively pivotable between aretracted position to deployed positions upon application of adeployment motion thereto. The surgical instrument further comprises atleast one tissue acquisition pin that corresponds to each one of the atleast one tissue acquisition members. Each tissue acquisition pinradially protrudes outward from the distal end of the tissue acquisitionshaft to impale tissue drawn in towards the tissue acquisition shaft bythe tissue acquisition members when the tissue acquisition members aremoved from the deployed to the retracted position.

In connection with yet another general aspect of various embodiments ofthe present invention, there is provided a surgical procedure forperforming a circular anastomosis of a tubular organ. In variousembodiments, the surgical procedure comprises inserting a stapler headof a surgical instrument into the tubular organ adjacent a targetedportion thereof. The stapler head operably supports a staple cartridgetherein that has a fastener face. The procedure further includesacquiring a proximal portion of the tubular organ that is adjacent tothe targeted portion with a plurality of tissue acquisition members ofthe surgical instrument. The procedure further comprises severing theproximal portion of the tubular organ from the targeted portion with theplurality of tissue acquisition members and retaining the proximalportion of the tubular organ adjacent to the fastener face of the staplecartridge. In various embodiments, the surgical procedure furtherinvolves severing the targeted portion of the tubular organ from adistal portion of the tubular organ and inserting an anvil into thedistal portion of the tubular organ such that a connection portion ofthe anvil protrudes proximally out of an open end of the distal portionof the tubular organ. The procedure further comprises securing thedistal portion of the tubular organ to the anvil and coupling theconnection portion of the anvil to the surgical instrument. Thereafter,the procedure comprises drawing the anvil proximally toward the staplerhead such that a proximal end of the distal portion of the tubular organand the retained proximal portion of the tubular organ are adjacent toeach other and captured between the anvil and the fastener face andthereafter stapling the proximal end of the distal portion and theretained proximal portion together to form a repaired tubular organ. Theprocedure further includes cutting through the proximal end of thedistal portion and retained proximal portion adjacent to the staples.

In various embodiments, a surgical instrument comprising an elongateshaft assembly and a plurality of arcuate tissue acquisition members isdisclosed. The elongate shaft assembly operably supports a circularsurgical staple cartridge in a distal end thereof. The plurality ofarcuate tissue acquisition members are pivotally attached to theelongate shaft assembly and configured to be selectively radiallydeployable from a first position wherein the plurality of arcuate tissueacquisition members cooperate to form a continuous ring defining acontinuous outer ring diameter and a second deployed position whereineach arcuate tissue acquisition member extends radially outward from theelongate shaft assembly. The surgical instrument further comprises meansfor selectively deploying the plurality of arcuate tissue acquisitionmembers between the first position and the second deployed position. Thesurgical instrument further comprises a tissue cutting member comprisingtwo diametrically opposed ends forming a plurality of tissue cuttingedges. The tissue cutting member comprises a tissue cutting diameterthat does not exceed the continuous outer ring diameter formed by theplurality of arcuate tissue acquisition members when the plurality ofarcuate tissue acquisition members are in the first position. Thesurgical instrument further comprises means for selectively rotating thetissue cutting member relative to the plurality of arcuate tissueacquisition members.

In various embodiments, a circular surgical fastening instrumentcomprising an elongate shaft assembly, a plurality of arcuate tissueacquisition members, a rotary drive shaft, a tissue cutting member, ananvil shaft assembly, and an anvil is disclosed. The elongate shaftassembly operably supports a circular surgical fastener cartridge in adistal end thereof. The plurality of arcuate tissue acquisition membersare pivotally attached to the elongate shaft assembly and configured tobe selectively radially deployable from a first position wherein theplurality of arcuate tissue acquisition members cooperate to form acontinuous ring defining a continuous outer ring diameter and a seconddeployed position wherein each arcuate tissue acquisition member extendsradially outward from the elongate shaft assembly. The rotary driveshaft protrudes through the circular surgical fastener cartridge andoperably interfaces with the plurality of arcuate tissue acquisitionmembers for applying rotary deployment motions thereto. The tissuecutting member comprises two diametrically opposed ends forming aplurality of tissue cutting edges. The tissue cutting member comprises atissue cutting diameter that does not exceed the continuous outer ringdiameter formed by the plurality of arcuate tissue acquisition memberswhen the plurality of arcuate tissue acquisition members are in thefirst position. The anvil shaft assembly is supported for selectiveaxial travel relative to the rotary drive shaft. The anvil is configuredto be removably attached to a distal end of the anvil shaft assemblysuch that when attached thereto, the anvil is in confrontingrelationship relative to the circular surgical fastener cartridge. Thecircular surgical fastening instrument further comprises means forselectively deploying fasteners from the circular surgical fastenercartridge.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain the principles of the present invention.

FIG. 1 is a perspective view of a surgical circular stapling instrumentof various non-limiting embodiments of the present invention;

FIG. 1A is a cross-sectional view of the handle portion of variousembodiments of the surgical stapling instrument of the presentinvention;

FIG. 2 is a cross-sectional view of a distal end portion of theelongated shaft of the circular stapling instrument of FIG. 1;

FIG. 2A is a partial cross-sectional view of the distal end of theelongated shaft with an anvil coupled thereto;

FIG. 2B is a partial cross-sectional view of the distal end of theelongated shaft taken along line 2B-2B in FIG. 2A;

FIG. 2C is a cross-sectional view of a portion of the handle assembly ofan embodiment of the present invention;

FIG. 2D is a cross-sectional view of another portion of the elongatedshaft of various embodiments of the present invention;

FIG. 3 is an end view of the elongated shaft of FIG. 2;

FIG. 4 is a partial perspective view of the distal end portion of theelongated shaft of FIGS. 2 and 3 with the tissue acquisition members andthe knife members thereof in their radially deployed positions;

FIG. 5 is a partial cross-sectional view of the distal end of theelongated shaft with an anvil coupled thereto and inserted into aportion of a patient's tubular organ such as a colon;

FIG. 6 is another cross-sectional view of the distal end of theelongated shaft of FIG. 5 with the anvil removed therefrom;

FIG. 7 is another cross-sectional view of the distal end of theelongated shaft of FIGS. 5 and 6 with the distal end portion of thecutter housing being axially advanced beyond the distal face of thestaple cartridge supported in the distal end of the elongated shaft;

FIG. 8 is another cross-sectional view of the distal end of theelongated shaft of FIG. 7 with tissue acquisition members being radiallydeployed out of the tissue acquisition housing and piercing through aportion of the colon;

FIG. 9 is another cross-sectional view of the distal end of theelongated shaft of FIG. 8 with the tissue acquisition members thereofbeing withdrawn back into the tissue acquisition housing to position thepunctured portion of the colon adjacent to the distal face of the staplecartridge;

FIG. 10 is another cross-sectional view of the distal end of theelongated shaft of FIG. 9 with the knife members radially deployed outof the cutter housing and puncturing through another portion of thecolon;

FIG. 11 is another cross-sectional view of the distal end of theelongated shaft of FIG. 10 after the knife members have been rotated tosever the retained punctured portion of colon from a diseased portion ofthe colon;

FIG. 12 is another cross-sectional view of the distal end of theelongated shaft of FIG. 11 with the knife members withdrawn back intotheir respective lumens in the cutter housing;

FIG. 13 is another cross-sectional view of the distal end of theelongated shaft of FIG. 12 after an anvil has been secured to a distalportion of the colon and the anvil stem thereof has been coupled to theanvil assembly portion of the circular stapling instrument;

FIG. 14 is another cross-sectional view of the distal end of theelongated shaft of FIG. 13 after the anvil has been drawn adjacent tothe distal face of the staple cartridge;

FIG. 15 is another cross-sectional view of the distal end of theelongated shaft of FIG. 14 after the staples have been deployed andannular knife has been axially advanced through the adjacent portions ofcolon;

FIG. 16 is another cross-sectional view of the distal end of theelongated shaft of FIG. 15 after the colon sections have been stapledtogether, but prior to being withdrawn from the colon;

FIG. 17 is a perspective view of a surgical circular stapling instrumentof various non-limiting embodiments of the present invention;

FIG. 18 is a cross-sectional view of a distal end portion of theelongated shaft of the circular stapling instrument of FIG. 17;

FIG. 19 is an exploded assembly view of the acquisition and deploymentshafts of various non-limiting embodiments of the present invention;

FIG. 20 is a partial perspective view of the acquisition shaft of FIG.19 with the tissue arms thereof in a retracted position;

FIG. 21 is a partial cross-sectional view of the acquisition shaft ofFIGS. 19 and 20, with the tissue arms thereof in a deployed position;

FIG. 22 is a perspective view of the acquisition shaft of FIG. 21;

FIG. 23 is a cross-sectional view of the elongated shaft of variousnon-limiting embodiments of the present invention, with an anvilattached thereto and inserted into a portion of a patient's colon;

FIG. 24 is another cross-sectional view of the elongated shaft of FIG.23, with the anvil removed and the acquisition arms deployed through aproximal portion of the colon that is adjacent to a target or diseasedportion of the colon;

FIG. 25 is a top cross-sectional view of the elongated shaft of FIG. 24taken along line 25-25 in FIG. 24 with the tissue acquisition armsextended through the proximal portion of the colon;

FIG. 26 is a partial cross-sectional view of the elongated shaft ofFIGS. 24 and 25 with the targeted or diseased portion of the colon beingremoved with a grasping instrument;

FIG. 27 is a top cross-sectional view of the elongated shaft of FIG. 26taken along line 27-27 in FIG. 26;

FIG. 28 is a partial cross-sectional view of the elongated shaft afterthe anvil has been inserted into a distal portion of the colon andsecured thereto by a purse-string suture arrangement;

FIG. 29 is a cross-sectional view of the elongated shaft of FIG. 28after the anvil has been coupled to the anvil assembly thereof and drawninto confronting relationship with the stapling cartridge therein;

FIG. 30 is a cross-sectional view of the elongated shaft of FIG. 29after the staple cartridge had been fired and the annular cutting memberadvanced through the stapled tissue portions;

FIG. 31 is a cross-sectional view of the elongated shaft of FIG. 30being withdrawn from the colon after completion of the staplingprocedure;

FIG. 32 is a perspective view of another a surgical circular staplinginstrument of various non-limiting embodiments of the present invention;

FIG. 33 is a cross-sectional view of a distal end portion of theelongated shaft of the circular stapling instrument of FIG. 32;

FIG. 34 is a partial perspective view of a hook and detection housingportion of the elongated shaft of FIG. 33 with the detection membersthereof in a retracted position;

FIG. 35 is another partial perspective view of the hook and detectionhousing of FIG. 34 with the detection members thereof in a deployedorientation;

FIG. 36 is a partial cross-sectional view of the distal end of theelongated shaft with the detection members thereof in a deployedorientation within a colon;

FIG. 37 is a top cross-sectional view of the elongated shaft and colonof FIG. 36 taken along line 37-37 in FIG. 36;

FIG. 38 is a perspective view of another circular stapling instrument ofvarious non-limiting embodiments of the present invention;

FIG. 39 is a cross-sectional view of a distal end portion of theelongated shaft of the circular stapling instrument of FIG. 38 insertedinto the proximal portion of a tubular organ such as a colon;

FIG. 40 is an exploded assembly view of distal end portions of a tissueacquisition shaft, a deployment shaft and a knife shaft of variousnon-limiting embodiments of the present invention;

FIG. 41 is a partial perspective view of the tissue acquisition shaft ofFIG. 40 with the tissue arms thereof in a retracted position;

FIG. 42 is a perspective view of the acquisition shaft of FIG. 41 withthe tissue arms thereof in deployed positions;

FIG. 43 is a partial cross-sectional view of a distal end portion of theelongated shaft of the surgical instrument of FIG. 38 inserted into aproximal portion of the colon with the anvil assembly removed therefrom;

FIG. 44 is a partial cross-sectional view of the distal end portion ofthe elongated shaft with the tissue acquisition arms deployed through aproximal portion of the colon;

FIG. 45 is a top cross-sectional view of the distal end portion of theelongated shaft take along line 45-45 in FIG. 44;

FIG. 46 is another partial cross-sectional view of the distal endportion of the elongated shaft after the tissue acquisition arms havebeen deployed through the proximal portion of the colon and then movedto a retracted position wherein the pierced proximal portion is trappedbetween the tissue acquisition arms and the tissue acquisition shaft;

FIG. 47 is a top cross-sectional view of the distal end portion of theelongated shaft of FIG. 46 taken along line 47-47 in FIG. 46;

FIG. 48 is a partial cross-sectional view of the distal end portion ofthe elongated shaft with the diseased portion of the colon being severedfrom the proximal portion and distal portion and being removed from thecolon by conventional graspers;

FIG. 49 is a partial cross-sectional view of the elongated shaft afterthe anvil has been inserted into a distal portion of the colon andsecured thereto by a purse-string suture arrangement;

FIG. 50 is a cross-sectional view of the elongated shaft of FIG. 49after the anvil has been coupled to the anvil assembly thereof and drawninto confronting relationship with the staple cartridge therein;

FIG. 51 is a cross-sectional view of the elongated shaft of FIG. 50after the staple cartridge had been fired and the annular cutting memberadvanced through the stapled tissue portions;

FIG. 52 is a cross-sectional view of the elongated shaft of FIG. 51being withdrawn from the colon after completion of the staplingprocedure;

FIG. 53 is a view of a portion of a patient's opened abdominal cavityillustrating various tissues and structures adjacent a portion of thecolon;

FIG. 54 is another partial view of the open abdominal cavity of FIG. 53;

FIG. 55 is another view of the abdominal cavity of FIG. 53 illustratingthe insertion of a trocar into the abdominal cavity to deliver aprotective sheath embodiment of the present invention therein;

FIG. 56 is another view of the abdominal cavity of FIG. 55 with theprotective sheath embodiment being withdrawn from the trocar sleeve by aconventional grasping device;

FIG. 57 is another view of the abdominal cavity of FIG. 56 illustratingone method of positioning the protective sheath around the circumferenceof a portion of the colon to be treated; and

FIG. 58 is another view of the abdominal cavity of FIG. 57 after theprotective sheath embodiment has been positioned around the outercircumference of the portion of colon to be treated.

DETAILED DESCRIPTION

The Applicant of the present application also owns the U.S. PatentApplications identified below which were filed on Jul. 30, 2010 andwhich are each herein incorporated by reference in their respectiveentirety:

U.S. patent application Ser. No. 12/846,978, entitled SURGICAL CIRCULARSTAPLER WITH TISSUE RETENTION ARRANGEMENTS, now U.S. Pat. No. 8,801,735;

U.S. patent application Ser. No. 12/846,956, entitled TRANSWALLVISUALIZATION ARRANGEMENTS AND METHODS FOR SURGICAL CIRCULAR STAPLERS,now U.S. Pat. No. 8,672,207;

U.S. patent application Ser. No. 12/846,968, entitled CIRCULAR STAPLINGINSTRUMENTS WITH SECONDARY CUTTING ARRANGEMENTS AND METHODS OF USINGSAME, now U.S. Pat. No. 8,801,734; and

U.S. patent application Ser. No. 12/846,952, entitled APPARATUS ANDMETHODS FOR PROTECTING ADJACENT STRUCTURES DURING THE INSERTION OF ASURGICAL INSTRUMENT INTO A TUBULAR ORGAN, now U.S. Patent ApplicationPublication No. 2012/0029272.

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the various embodiments of the present invention is definedsolely by the claims.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment”, or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation. Such modifications and variations are intended to beincluded within the scope of the present invention.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical”, “horizontal”, “up”, and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

FIG. 1 illustrates a circular stapler 10 according to variousnon-limiting embodiments of the invention. In various embodiments, thecircular stapler 10 includes a handle assembly 12 that has an elongatedshaft assembly 14 protruding therefrom that defines a central axis A-A.The elongate shaft assembly 14 includes a rigid outer sheath 16 that hasa distal end portion 17 that forms a stapler head 20. In variousnon-limiting embodiments, the stapler head 20 is configured to operablysupport a circular staple cartridge 30 therein. Such circular staplecartridges 30 are known in the art and may generally support one, two,or more circumferentially spaced and staggered rows of staples 36therein. See FIGS. 2 and 3. The embodiment depicted in FIG. 3, forexample, has two rows 32, 34, of staples 36. A conventional annularknife 40 is coaxially and movably supported within the stapler head 20.

In certain implementations, the circular stapler 10 further includes afiring shaft assembly 50 that is supported within the outer sheath 16for selective axial travel therein. See FIG. 2. A distal end portion 52of the firing shaft assembly 50 has an outer staple driver portion 54thereon for engagement with each of the staples 36 in the outer row 32of staples 36 in the staple cartridge 30. In addition, the distal endportion 52 of the firing shaft assembly 50 has an inner staple driverportion 56 that is configured for engagement with each of the staples 36in the inner row 34 of staples 36 within the staple cartridge 30. As canalso be seen in FIG. 2, for example, the distal end portion 52 of thefiring shaft assembly 50 further has a ledge 58 that is configured toengage the annular knife 40. Thus, as will be discussed in furtherdetail below, axial advancement of the firing shaft assembly 50 in adistal direction “DD”, will cause the staples 36 to be driven out of thestaple cartridge 30 as well as the annular knife 40 to be advanceddistally. As can be seen in FIG. 2A, the firing shaft assembly 50 has abase portion 51 that is coupled to a firing rod 53.

In various non-limiting embodiments, the firing rod 53 operablyinterfaces with a firing trigger 60 that is operably coupled to thehandle assembly 12. See FIGS. 1 and 1A. As can be seen in FIGS. 1 and1A, the firing trigger 60 is pivotally coupled to the handle assembly 12such that when the firing trigger 60 is pivoted toward the handleassembly 12, the firing shaft assembly 50 is moved in the distaldirection DD. Such firing trigger arrangements are known in the art andtherefore will not be discussed in detail herein. For example, anexemplary firing trigger arrangement is disclosed in U.S. PatentApplication Publication No. 2008/0078806, entitled SURGICAL STAPLINGINSTRUMENT WITH MECHANICAL INDICATOR TO SHOW LEVELS OF TISSUECOMPRESSION, now U.S. Pat. No. 8,348,131, the disclosure of which isherein incorporated by reference in its entirety.

As shown in FIGS. 2 and 2A, various non-limiting embodiments include anacquisition housing 70 that is coaxially supported within the firingshaft assembly 50 and is axially movable relative thereto. Theacquisition housing 70 has a plurality of acquisition lumens 72 thereinthat each movably support an acquisition or hook member 80. As can beseen in FIG. 3, for example, the plurality of three-sided acquisitionlumens 72 may be equally spaced around the circumference of theacquisition housing 70. In the non-limiting embodiment depicted in FIG.3, a total of eight (8) acquisition lumens 72 are equally spaced aroundthe circumference of the acquisition housing 70.

Each acquisition or hook member 80 may be fabricated from, for example,Nitinol, 300 or 400 series stainless steel (fully or three-fourthshardened) and have a distal end portion 82 that, when advanced out ofits respective acquisition lumen 72, bends radially outward as shown inFIG. 4. As can also be seen in FIG. 4, each hook member 80 has a tissuebarb 84 formed on the distal end portion 82 thereof. As can be seen inFIGS. 2 and 3, in various non-limiting embodiments, a sleeve 78 isemployed to facilitate installation of the hook members 80 into theirrespective lumens 72.

As can be seen in FIG. 2A, each of the hook members 80 are coupled to orprotrude from an acquisition ring 81 that has a pair of acquisition rods83 attached thereto. The acquisition rods 83 are attached to a hookswitch 90 that is operably supported on the handle assembly 12. SeeFIGS. 1 and 2C. As the surgeon moves the hook switch 90 in a distaldirection (arrow 92 in FIGS. 1 and 2C), the acquisition housing 70 movesdistally. Such movement of the acquisition housing 70 causes the distalend portion 84 of each hook member 80 to be advanced distally out of itsrespective acquisition lumen 72. As the distal end portion 84 of eachhook member 80 is advanced out of the acquisition lumen 72, the naturalbending action of the hook member 80 causes the end portion 84 to bendradially away from the central axis A-A as illustrated in FIG. 4. Thesurgeon may retract the acquisition housing 70 and the hook members 80into their starting positions (FIG. 2), by moving the hook switch 90 ina proximal direction (arrow 94 in FIGS. 1 and 2C).

As can be further seen in FIGS. 2, 2A, 2D, 3 and 4, in variousnon-limiting embodiments, a cutter housing 100 is coaxially supportedwithin the acquisition housing 70. The cutter housing 100 is supportedfor selective axial travel relative to the acquisition housing 70 andfor selective axial travel along central axis A-A. In variousembodiments, a pair of housing actuation rods 101 protrude from thecutter housing 100 to interface with a knife knob 110 that is movablysupported on the handle assembly 12. See FIGS. 1 and 2D. In variousnon-limiting embodiments, the knife knob 110 is supported on the handleassembly 12 such that it can move axially (represented by arrows 112,114 in FIGS. 1 and 2D) and also be rotated relative to the handleassembly 12 (represented by arrow 116 in FIG. 1). The housing actuatorrods 101 are attached to the knife knob 110 such that movement of theknife knob 110 in an axial direction moves the cutter housing 100axially within the acquisition housing 70 and rotation of the knife knob110 also rotates the cutter housing 100 about the central axis A-A aswill be discussed in further detail below.

In various non-limiting embodiments, the cutter housing 100 includes atleast one, and preferably a plurality of, knife lumens 102 that extendaxially through the wall of the cutter housing 100. As can be seen inFIG. 3, for example, the plurality of knife lumens 102 may be spacedequally around the circumference of the cutter housing 100. In thenon-limiting embodiment depicted in FIG. 3, a total of eight (8) knifelumens 102 are equally spaced around the circumference of the cutterhousing 100. As can be seen in FIGS. 2 and 4, each knife lumen 102 has acurved distal end portion 104 that opens radially outward.

In various non-limiting embodiments, a flexible knife member 120 isslidably received within each knife lumen 102. Each flexible knifemember 120 has a sharpened distal end 122 and is attached to orprotrudes from a knife ring 123. A pair of knife actuator rods 125 areattached to the knife ring 123 by a slip joint arrangement 127 thatpermits the knife ring 123 to rotate relative to the actuator rods 125.See FIG. 2A. As can be seen in FIG. 2C, the knife actuator rods 125(only one knife actuator rod 125 is shown in that view) are attached toa knife switch 130 that is operably mounted to the handle 12. The distalend 122 of each knife member 120 is substantially pointed to enable itto pierce through tissue and it may have at least one cutting edge 124formed thereon. When the knife switch 130 is moved in the distaldirection (arrow 132), the knife members 120 are moved distally withinthe knife lumens 102 such that the sharpened distal end 122 “naturally”flexes or bends radially out of the curved distal end portion 104 of thelumen 102 as shown in FIG. 4. As used in this context, the term“naturally” means that the material may be prestressed or otherwiseformed such that the distal end thereof flexes or bends as it exits thelumen. Likewise, movement of the knife switch 130 in the proximaldirection (represented by arrow 134 in FIGS. 1 and 2C) causes each knifemember 120 to be retracted back into its knife lumen 102. In variousnon-limiting embodiments, the knife members 120 may be fabricated from,for example, Nitinol, 300 or 400 series stainless steel (fully orthree-fourths hardened).

As can also be seen in FIG. 2A, the firing shaft assembly 50 has adistal end post 140 that protrudes from the base portion 51 andcoaxially extends within the cutter housing 100 for selective axialtravel therein. Various embodiments also include a bulkhead member 141that is mounted within the outer sheath 116. To facilitate easyassembly, the outer sheath 16 may comprise a distal outer sheath segment16 and a proximal outer sheath segment 16′ as shown in FIG. 2A. Inaddition, a distal end post 142 extends from the bulkhead 51 andsupports a distal anvil connector 150. The distal anvil connector 150 iscoupled to a distal band assembly 151. The distal band assembly 151 iscoupled to a control rod assembly 153 that interfaces with an adjustmentknob 160 that is rotatably supported on the handle assembly 12. Suchanvil shaft assemblies and control knob arrangements are generallyknown. For example, the control rod assembly and control knob may beconfigured as disclosed in published U.S. Patent Application No.2008/0078806, entitled SURGICAL STAPLING INSTRUMENT WITH MECHANICALINDICATOR TO SHOW LEVELS OF TISSUE COMPRESSION, now U.S. Pat. No.8,348,131, which has been herein incorporated by reference.

As can be seen in FIG. 2B, each of the housing actuator rods 101protrude through a corresponding arcuate slot 145 in the bulkhead 141.The slots 145 may be sized to define/limit the amount that the cutterhousing 100 may be rotated relative to the central axis A-A. Forexample, in one embodiment wherein a total of eight (8) knife members120 are employed, the slots 145 may be sized to facilitate at leastapproximately 45°-50° of arcuate or rotational travel of the cutterhousing 100 about the central axis A-A. The bulkhead 141 may furtherhave an aperture 146 for permitting the distal band assembly 151 toprotrude therethrough. In addition, each of the knife actuator rods 125extends through a corresponding opening 147 in the bulkhead 141.Similarly, each of the acquisition rods 83 extend through acorresponding aperture 148 in the bulkhead 141. See FIG. 2B.

The circular stapler 10 further includes an anvil 170 as shown in FIG.5. In various non-limiting embodiments, the anvil 170 includes an anvilbase 171 that has a series of staple forming pockets 172 therein and ananvil shaft 174 that is removably attachable to the distal anvilconnector 150. In particular, a coupling stem 176 protrudes from theproximal end 175 of the anvil shaft 174 and is sized to be slidablyreceived in a passage 152 in the distal anvil connector 150. The anvil170 further has an anvil cap 178 thereon as illustrated in FIGS. 5 and13 that defines a tissue cavity 179 therein.

One exemplary method of using the circular stapler 10 will be describedwith reference to FIGS. 5-16. The various embodiments of the circularstapler 10 are particularly well-suited for performing a circularanastomosis of a tubular organ such as, for example, the colon. Turningfirst to FIG. 5, the stapler head 20 is inserted into a proximal portion201 of the colon 200 through the patient's anus 199. In applicationswherein a diseased or targeted portion 202 of colon is to be removed,the stapler head 20 is positioned adjacent to the diseased portion 202.See FIG. 6.

Once the stapler head 20 has been inserted to the appropriate positionrelative to the diseased portion 202, the cutter housing 100 is advanceddistally by axially advancing the knife knob 110 in a distal direction(represented by arrows 112 in FIGS. 1 and 7). At this stage in theprocedure, the knife members 120 have not been advanced out of theirrespective knife lumens 102. Thereafter, the surgeon advances theacquisition housing 70 distally by moving the hook switch 90 in thedistal direction (arrow 92 in FIG. 1). Movement of the acquisitionhousing 70 in the distal direction causes the hook members 80 to moveaxially out of their respective acquisition lumens 72. As the distalends of the hook members 80 exit their respective acquisition lumens 72,they naturally flex radially outward to engage and pierce through theproximal portion 201 of the colon 200. See FIG. 8. Once the hook members80 have pierced and engaged the proximal portion 201 of the colon 200,the surgeon moves the hook switch 90 in the proximal direction(represented by arrow 94 in FIG. 1) to retract the hook members 80 intotheir respective acquisition lumens 72 as well as to retract theacquisition housing 100 back to its starting position. The barbs 84 onthe distal ends of the hook members 80 draw the engaged the proximalportion 201 into the position illustrated in FIG. 9. Thus, the engagedproximal portion 201 of the colon 200 is drawn over a distal face 31 ofthe staple cartridge 30 and partially into the interior space 33 betweenthe staple cartridge 30 and the cutter housing 100.

Once the engaged proximal portion 201 of the colon 200 has been drawninto the position illustrated in FIG. 9, the surgeon then extends theknife members 120 out of their respective knife lumens 102 by axiallyadvancing the knife knob 110 on the handle assembly 12 in the distaldirection (represented by arrow 112 in FIG. 1). By moving the knife knob110 distally, the knife members 120 are advanced out of their knifelumens 102 and the curved portion 104 of each knife lumen 102 causes theknife member 120 therein to move radially outward as illustrated in FIG.10. The knife members 120 protrude through the proximal portion 201 ofthe colon 200 that is proximal to the diseased colon portion 202. SeeFIG. 10. Thereafter, the diseased colon portion 202 may be severed fromthe proximal colon portion 201 by rotating the knife knob 110 on thehandle assembly 12 (represented by arrow 116 in FIG. 1).Rotation/actuation of the knife knob 110 will cause the cutter housing100 and the knife members 120 to rotate about the central axis A-A andcut through the colon tissue. After the diseased portion 202 has beencut away from the proximal colon portion 201 (FIG. 11), the surgeon mayretract the knife members 120 back into their respective knife lumens102 by moving the knife knob 110 in a proximal direction (represented byarrow 114 in FIG. 1). See FIG. 12.

The diseased portion 202 may be severed from the distal colon portion208 (FIG. 13), by means of, for example, a conventional laparoscopictissue severing device (not shown) that has been inserted through atrocar sleeve that extends into the abdominal cavity 601 that isadjacent to the diseased portion 202. The diseased colon portion 202 maythen be removed through the trocar sleeve. The surgeon then orients theanvil 170 within the distal colon portion 206 such that the anvil shaft174 protrudes out of the distal colon portion 206 as shown in FIG. 13.The surgeon then ties the end of the distal colon portion 206 around theanvil shaft 174 using what is known in the art as a “purse stringsuture” 220. Once the distal colon portion 206 has been sutured aroundthe anvil shaft 174, the coupling stem 176 of the anvil shaft 174 isinserted into the passage 152 in the anvil shaft assembly 150. Thecoupling stem 176 may be sized relative to the passage 152 to establisha frictional fit therebetween to retain the coupling stem 176 therein,yet permit the coupling stem 176 to be removed therefrom at a latertime.

The surgeon then draws the anvil 170 toward the stapler head 20 (in theproximal direction “PD”) by rotating the anvil control knob 160 in theappropriate direction until colon portions 205, 210 are clamped betweenthe anvil 170 and the staple cartridge 30 as shown in FIG. 14.Thereafter, the surgeon actuates the firing trigger 60 to axiallyadvance the firing shaft assembly 50 in the distal direction “DD”. Asfiring shaft assembly 50 is advanced distally, the outer staple driverportion 54 and the inner staple driver portion 56 serve to drive thestaples 36 located in the outer row 32 and inner row 34, respectively,through the colon portions 205, 210 into the anvil forming pockets 172in the anvil base 171. The firing shaft assembly 50 also advances theannular knife 40 through the colon portion 205 to cut the portion 201therefrom. See FIG. 15. Further advancement of the annular knife 40severs colon portion 207 from colon portion 208. The surgeon then movesthe anvil 170 in the distal direction “DD” to release the stapled colonportions 205, 210 from between the anvil base 171 and the face 31 of thestaple cartridge 30. See FIG. 16. The instrument 10 may then be removedfrom the colon 200. The cut portion 201 remains in the stapler head 20and the cut portion 207 remains in the tissue cavity 179 in the anvil170 as the surgeon withdraws the instrument 10 out through the patient'sanus 199. Thus, the cut portions 201, 207 of the colon 200 are removedfrom the repaired colon when the instrument is withdrawn therefrom.

FIG. 17 illustrates another circular stapler 300 according to variousnon-limiting embodiments of the invention. The circular stapler 300generally includes a handle assembly 312 that has an elongated shaft 314protruding therefrom. The elongated shaft 314 may define a central axisA-A. As can be seen in FIG. 17, the elongate shaft 314 includes a rigidouter sheath 316 that supports a stapler head 320 thereon. In variousnon-limiting embodiments, the stapler head 320 is configured to supporta circular staple cartridge 330 therein. Such circular staple cartridges330 are known in the art and generally support one or two or morecircumferentially spaced and staggered rows of staples 36 therein as wasdescribed hereinabove. A conventional annular knife 340 is coaxially andmovably supported within the staple cartridge 330. See FIG. 18.

In certain implementations, the circular stapler 300 further includes afiring shaft 350 that is operably supported within the rigid outersheath 316 for selective axial travel therein as was discussed above.See FIG. 18. A distal end portion 352 of the firing shaft 350 has anouter staple driver portion 354 thereon for engagement with each of thestaples 36 in the outer row 32 of staples 36 in the staple cartridge330. In addition, the distal end portion 352 of the firing shaft 350 hasan inner staple driver portion 356 configured for engagement with eachof the staples 36 in the inner row 34 of staples 36 within the staplecartridge 330. As can also be seen in FIG. 18, for example, the distalend portion 352 of the firing shaft 350 further has a flanged portion358 that is configured to engage the annular knife 340. Thus, as will bediscussed in further detail below, axial advancement of the firing shaft350 in a distal direction “DD”, will cause the staples 36 to be drivenout of the staple cartridge 330 as well as the annular knife 340 toadvanced distally.

In various non-limiting embodiments, the firing shaft 350 interfaceswith a firing trigger 360 that is operably coupled to the handleassembly 312. As can be seen in FIG. 17, the firing trigger 360 ispivotally coupled to the handle assembly 312 such that when the firingtrigger 360 is pivoted toward the handle assembly 312, the firing shaft350 is moved in the distal direction DD. As was discussed above, suchfiring trigger arrangements are known in the art and therefore will notbe discussed in detail herein.

As shown in FIG. 18, various non-limiting embodiments also include adeployment shaft 370 that is coaxially and rotatably supported within atissue acquisition shaft 380 that is non-rotatably supported within theelongated shaft 316. The proximal end of the deployment shaft 370operably interfaces with a tissue acquisition knob 310 that is rotatablysupported on the handle assembly 312. The deployment shaft 370interfaces with the tissue acquisition knob 310 in the manner describedabove with respect to knife knob 110. Thus, rotation/actuation of thetissue acquisition knob 310 on the handle assembly 312 will result inthe rotation of the deployment shaft 370 within the tissue acquisitionshaft 380 about the central axis A-A. More specifically and withreference to FIG. 19, in various embodiments, a distal end 372 of thedeployment shaft 370 protrudes through a hole 382 in the acquisitionshaft 380 and has a drive gear 374 attached thereto. A distal end 384 ofthe acquisition shaft 380 is configured to operably support at least twotissue acquisition members or tissue arms 400 thereon. In thenon-limiting embodiment depicted in FIG. 19, a total of four tissue arms400 are pivotally pinned to the distal end 384 of the tissue acquisitionshaft 380 by corresponding pins 386 such that each tissue arm 400 pivotsabout a corresponding “acquisition” axis B-B that is substantiallyparallel to the central axis A-A. See FIGS. 21 and 23.

As can be seen in FIGS. 19 and 22, each tissue arm 400 has a bodyportion 402 that may be fabricated from, for example, stainless steel(300 or 400 series), or titanium-steel composite or ceramic, etc. andhave a driven gear 404 attached thereto or formed thereon. The drivengear 404 of each tissue arm 400 is movably supported within acorresponding arm cavity 388 formed in the distal end 384 of the tissueacquisition shaft 380. Each driven gear 404 is in meshing engagementwith the drive gear 374 on the deployment shaft 370. Thus, rotation ofthe deployment shaft 370 will result in the pivotal deployment of thetissue arms 400 from the retracted position depicted in FIG. 20 to thedeployed position depicted in FIG. 22. As can be seen in FIGS. 20 and22, in various embodiments, each tissue arm 400 has an arcuate shapesuch that when the tissue arms 400 are in a retracted position as shownin FIG. 20, they cooperate to create a round disc-like assembly 401 atthe distal end of the tissue acquisition shaft 380.

In various embodiments, the body portion 402 of each tissue arm 400further has a tissue piercing tip 406 formed thereon or otherwiseattached thereto. In addition, an arm knife 408 that has a cutting edge410 formed thereon is attached to or is otherwise formed on the bodyportion 402 of each tissue arm 400. In various embodiments, the armknife 408 may be fabricated from, for example, stainless steel (300 or400 series), or titanium-steel composite or ceramic, etc. and beattached to the body portion 402 of the corresponding tissue arm 400 by,depending upon the material, welding or other suitable attachmentmethod. In the preferred embodiments, if the arm knife 408 is fabricatedfrom any of the metal materials identified above, it may be desirablefor such material to be hardened. For example, a Rockwell hardness valueof 38-52 may be desirable. In alternative embodiments, the arm may befabricated with a thin feature that could be ground to a sharp edge. Aswill be appreciated as the present Detailed Description proceeds, theblade works more like a scissors rather than a knife as it cuts whenclosed such that it shears the tissue when 408 closes against 421. Ascan also be seen in FIG. 19, a shear plate 420 is attached to the distalend 382 of the arm shaft 380 by threaded fasteners 422 that extend intothreaded fastener bores 424 in the arm shaft 380. Also in variousembodiments, a plurality of tissue acquisition pins 426 are equallyspaced around the circumference of the tissue acquisition shaft 380 andprotrude radially therefrom. The outer edge 421 of the shear plate 420cooperates with the cutting edges 410 on the tissue arms 400 to shearoff tissue that is drawn between those edges 410, 421 as the tissue arms400 are moved to their retracted position.

In certain implementations, a distal end post 442 protrudes from aportion of the firing shaft 350 that coaxially extends within thedeployment shaft 370 for selective axial travel therein. The distal endpost 442 supports a distal anvil connector 450 therein that is coupledto an adjustment knob 460 that is rotatably supported on the handleassembly 312 in the various manners discussed above.

The circular stapler 300 further includes an anvil 470 as shown in FIG.18. In various non-limiting embodiments, the anvil 470 includes an anvilbase 471 that has a series of staple forming pockets 472 therein. Theanvil base 471 may further define a shear edge 473 for facilitating theshearing of tissue by the annular knife 340. The anvil 470 furtherincludes an anvil shaft 474 that is removably attachable to the distalanvil connector 450. In particular, a coupling stem 476 protrudes fromthe proximal end 475 of the anvil shaft 474 and is sized to be slidablyreceived in a passage 452 in the anvil shaft assembly 450. See FIG. 23.The anvil assembly 470 further has an anvil cap 478 thereon that servesto define a tissue cavity 479 therein as illustrated in FIGS. 18 and 23.As can also be seen in FIG. 18, the disc-like assembly 401 is sized toextend into an opening 475 in the anvil base 471.

One exemplary method of using the circular stapler 300 will be describedwith reference to FIGS. 23-31. The various embodiments of the circularstapler 300 are particularly well-suited for performing a circularanastomosis of a tubular organ such as, for example, a colon 200.Turning first to FIG. 23, the stapler head 320 is inserted through thepatient's anus 199 into a proximal portion 201 of the colon 200. When adiseased or otherwise targeted portion 202 of colon 200 is to beremoved, the stapler head 320 is positioned in an area wherein thediseased portion 202 is to be severed from the proximal portion 201.

Once the stapler head 320 has been properly positioned within the colon,the tissue arms 400 may be radially deployed by rotating the tissueacquisition knob 310 in a first direction (represented by arrow 311 inFIG. 17) which also rotates the deployment shaft 370. Rotation of thedeployment shaft 370 in the first direction also rotates the drive gear374 which is in meshing engagement with the driven gear portions 404 ofeach tissue arm 400. Thus, rotation of the drive gear 374 in the firstdirection causes the tissue arms 400 to be radially deployed. As thetissue arms 400 are radially deployed, the tissue-piercing tips 406thereof pierce through the proximal portion 201 of colon 200. See FIGS.24 and 25. Once the tissue arms 400 have been deployed such that thetissue-piercing tips 406 thereof have pierced through the proximalportion 201 of colon 200, the surgeon may then rotate the tissueacquisition knob 310 in a second direction (represented by arrow 313 inFIG. 17) to move the tissue arms 400 to the retracted position. As thetissue arms 400 are retracted, they gather the pierced proximal portion201 of colon 200 and draw it inward toward the tissue acquisition shaft380. As the gathered colon 201 is drawn between the shear plate 420 andthe tissue arms, the portion 201 of the colon 200 that is capturedbetween the outer edge 421 of the shear plate 420 and the cutting edges410 on the tissue arms 400 is severed from the diseased portion 202 ofthe colon 200. Retraction of the tissue arms 400 causes the portion 201of the colon 200 to be impaled onto the tissue retention pins 426 andretained thereon as shown in FIG. 26. Thereafter, the diseased portion202 of the colon 200 may be transected from the distal colon portion 208using a conventional laparoscopic tissue severing instrument (not shown)inserted through a trocar sleeve inserted into the abdominal cavity 601.After the diseased portion 202 has been cut away from the distal colonportion 208, the diseased portion 202 may be removed through the trocarsleeve (not shown) with a conventional grasping instrument 600. See FIG.26.

The surgeon then orients the anvil 170 within the distal portion 208 ofthe colon 200 such that the anvil shaft coupling stem 476 of the anvilshaft 474 protrudes out of the distal portion 208 of the colon 200 asshown in FIG. 28. The surgeon then ties the end of the distal colonportion 208 around the anvil shaft 474 using what is known in the art asa “purse string suture” 220. Once the distal colon portion 208 has beensutured around the anvil shaft 474, the coupling stem 476 of the anvilshaft 474 is inserted into the passage 452 in the anvil shaft assembly450. The coupling stem 476 is sized relative to the passage 152 toestablish a frictional fit therebetween to retain the coupling stem 176therein, yet permit the coupling stem 176 to be removed therefrom at alater time. See FIG. 28.

The surgeon then draws the anvil 470 toward the stapler head 420 (in theproximal direction “PD”) by rotating the anvil control knob 460 in theappropriate direction until portions 205, 210 of the colon 200 areclamped between the anvil 470 and the staple cartridge 330 as shown inFIG. 29. Thereafter, the surgeon actuates the firing trigger 360 toaxially advance the firing shaft 350 in the distal direction “DD”. Asfiring shaft 350 is advanced distally, the staple driver portions 354,356 serve to drive the staples 36 through the portions 205, 210 of colon200 into the anvil forming pockets 472 in the anvil 470. The firingshaft 350 also advances the annular knife 340 through the colon portions205, 210 to sever portions 201, 207, respectively therefrom. The surgeonmay then move the anvil 470 in the distal direction “DD” to release thestapled colon portions 205, 210 from between the anvil 470 and thestapler head 320. The instrument 300 may then be removed from the colon200. See FIG. 31. The severed portions 201, 207 of the colon 200 remainin the stapler head 320 and the anvil 470, respectively as the surgeonwithdraws the instrument 300 out through the patient's anus. Thus, thesevered portions 201, 207 of the colon 200 are removed from the repairedcolon when the instrument 300 is withdrawn therefrom.

Circular stapling instruments are generally introduced through the anusand not from the abdomen side of the pelvis. Such method of entrycomplicates the ability of the surgeon to visualize the tumor, thetumor's necessary margins and those margin edges with respect to thedistal transection location to ensure that the stapler head has beenproperly positioned in the colon before commencing the transection.FIGS. 32-37 illustrate a circular stapler 700 according to variousnon-limiting embodiments of the invention that may provide feedback tothe surgeon during the insertion process. The circular stapler 700generally includes a handle assembly 712 that has an elongated shaftassembly 714 protruding therefrom. The elongated shaft assembly 714 maydefine a central axis A-A. As can be seen in FIG. 32, the elongate shaftassembly 714 includes a rigid outer sheath 716 that has a distal endportion that supports a stapler head 720 thereon. In variousnon-limiting embodiments, the stapler head 720 is configured to operablysupport a circular staple cartridge 730 therein. Such circular staplecartridges 730 are known in the art and generally may support one, twoor more than two circumferentially spaced and staggered rows of staplestherein. In the non-limiting embodiment depicted in FIG. 33, the staplecartridge 730 supports two rows 732, 734 of staples 36 therein. Aconventional annular knife 740 is coaxially and movably supported withinthe stapler head 720.

The circular stapler 700 further includes a firing shaft 750 that isoperably supported within the rigid outer sheath 716 for selective axialtravel therein. See FIG. 33. A distal end portion 752 of the firingshaft 750 has an outer staple driver portion 754 thereon for engagementwith each of the staples 36 in the outer row 732 of staples 36 in thestaple cartridge 730. In addition, the distal end portion 752 of thefiring shaft assembly 750 has an inner staple driver portion 756 that isconfigured for engagement with each of the staples 36 in the inner row734 of staples 36 within the staple cartridge 730. As can also be seenin FIG. 33, for example, the distal end portion 752 of the firing shaft750 further has a flanged portion 758 that is configured to engage theannular knife 740. Thus, as will be discussed in further detail below,axial advancement of the firing shaft 750 in a distal direction “DD”,will cause the staples 36 to be driven out of the staple cartridge 730as well as the annular knife 740 to advanced distally.

In various non-limiting embodiments, the firing shaft 750 interfaceswith a firing trigger 60 that is operably coupled to the handle assembly712. As can be seen in FIG. 32, the firing trigger 60 is pivotallycoupled to the handle assembly 712 such that when the firing trigger 60is pivoted toward the handle assembly 712, the firing shaft 750 is movedin the distal direction DD as was discussed above.

As shown in FIG. 33, various non-limiting embodiments include a hook anddetection housing 770 that is coaxially supported within the firingshaft 750 and axially movable therein. The hook and detection housing770 has a plurality of hook lumens 772 therein that each movablysupports an acquisition hook member 780 therein. As can be seen in FIG.34, for example, the plurality of three-sided hook lumens 772 may beequally spaced around the circumference of the hook and detectionhousing 770. For example, in the non-limiting embodiment depicted inFIG. 34, a total of eight (8) hook lumens 772 are equally spaced aroundthe circumference of the hook and detection housing 770. Each hookmember 780 may be fabricated from, for example, Nitinol, 300 or 400series stainless steel (fully or three-fourths hardened), etc. and havea distal end portion 782 that, when advanced out of its respective hooklumen 772, naturally flexes or bends radially outward in the mannersdescribed above. As with other embodiments, each acquisition hook member780 may have a tissue barb 784 formed on the distal end portion 782thereof. As can be seen in FIGS. 33 and 34, in various non-limitingembodiments, the hook and detection housing 770 includes a hook sleeve778 that facilitates installation of the acquisition hook members 780into their respective lumens 772.

In various non-limiting embodiments, a proximal end portion of the hookand detection housing 770 may operably interface with a hook switch 790that is operably supported on the handle 712. See FIG. 32. As thesurgeon moves the hook switch 790 in a distal direction (arrow 792 inFIG. 32), the hook and detection housing 770 moves distally. Inaddition, each acquisition hook member 780 is advanced distally out ofits respective hook lumen 772 as was described above. The surgeon mayretract the hook members 780 into their starting positions by moving thehook switch 790 in a proximal direction (arrow 794 in FIG. 32).

Also supported within the hook and detection housing 770 are a pluralityof flexible detection members 781. In particular, a plurality detectionlumens 774 are also provided in the hook and detection housing 770. Forexample, in the non-limiting embodiment depicted in FIG. 34, a total ofeight (8) detection lumens 774 are equally spaced around thecircumference of the hook and detection housing 770. In one non-limitingembodiment, each detection member 781 may be fabricated from, forexample, polyethylene, Nylon, Nitinol, titanium etc. and have a distalend portion 783 that, when deployed out of its respective detectionlumen 774, naturally flexes or bends radially outward as illustrated inFIG. 35. In addition, a substantially blunt or rounded bumper 785 may beprovided on the distal end of each detection member 781. In oneembodiment, the bumper may be fabricated from, for example, Sanoprene,Isoprene, natural rubber, polypropylene, polyethylene, Nylon, etc. Inother embodiments, the bumper 785 may comprise a light or light emittingdiode (LED). In those embodiments, a conductor may extend from a batteryin the handle assembly 712 or other energy source through a lumen in thedetection member 781 to the light 785.

In various non-limiting embodiments, a proximal end portion of eachdetection member 770 may interface with a detection knob 791 that isoperably supported on the handle assembly 712. See FIG. 32. As thesurgeon rotates the detection knob 791 in a first direction (arrow 793in FIG. 32), the detection members 781 deploy distally out of theirrespective lumens in a radial direction away from central axis A-A todeployed positions (FIG. 36). In various embodiments, for example, allof the detection members 781 may be attached to a round sleeve (notshown) that is slidably supported within the outer sheath 716. The roundsleeve may further have a gear rack attached thereto that is received inmeshing engagement with a gear (not shown) on the underside of thedetection knob 791. Rotation of the detection knob 791 in one directionmoves the sleeve distally and therefore extends all of the detectionmembers 781. When the surgeon rotates the detection knob 791 in a seconddirection (arrow 795 in FIG. 32), the detection members 781 are drawnback into their respective detection lumens 774 to the retractedposition. See FIG. 34. Other switches and drive arrangements could alsobe employed to selectively extend and retract the detection memberswithout departing from the spirit and scope of the present invention.

As can be further seen in FIG. 33, in various non-limiting embodiments,a cutter housing 800 is coaxially supported within the hook anddetection housing 770. The cutter housing 800 is supported for selectiveaxial travel relative to the hook and detection housing 770 and forselective axial travel along central axis A-A. The cutter housing 800interfaces with a knife knob 810 that is movably supported on the handleassembly 712. See FIG. 32. In various non-limited embodiments, the knifeknob 810 is supported on the handle assembly 712 such that it can moveaxially (represented by arrows 812, 814 in FIG. 32) and also be rotatedrelative to the handle assembly 712 (represented by arrow 816 in FIG.32). The cutter housing 800 may be attached to the knife knob 810 in thevarious manners described above such that movement of the knife knob 810in an axial direction moves the cutter housing 800 axially within thehook and detection housing 770 and rotation of the knife knob 810 alsorotates the cutter housing 800 about the central axis A-A.

In various non-limiting embodiments, the cutter housing 800 includes aplurality of knife lumens 802 that extend axially through the wall ofthe cutter housing 800. As was discussed above with respect to otherembodiments, the plurality of knife lumens 802 may be spaced equallyaround the circumference of the cutter housing 800. For example, in anon-limiting embodiment, a total of eight (8) knife lumens 802 may beequally spaced around the circumference of the cutter housing 800. Ascan be seen in FIG. 33, each knife lumen 802 has a curved distal endportion 804 that opens radially outward.

In various non-limiting embodiments, a flexible knife member 820 isslidably received within each knife lumen 802. Each flexible knifemember 820 has a sharpened distal end 822 and a proximal end (not shown)that interfaces with a knife switch 830 that is operably mounted to thehandle 712 in the various manners described above. See FIG. 32. Thedistal end 822 may be substantially pointed to enable it to piercethrough tissue and it may have at least one cutting edge formed thereon.When the knife switch 830 is moved in the distal direction (arrow 832),the knife members 820 are moved distally within the knife lumens 802such that the sharpened distal end 822 naturally flexes or bendsradially out of the curved distal end portion 804 of the lumen 802 aswas described above. Likewise, movement of the knife switch 830 in theproximal direction (represented by arrow 834 in FIG. 32), causes theknife members 820 to be retracted back into their respective knife lumen802. In various non-limiting embodiments, the knife members 820 may befabricated from, for example, Nitinol, 300 or 400 series stainless steel(fully of three-fourths hardened).

As can also be seen in FIG. 33, various non-limiting embodiments mayfurther include an anvil shaft assembly 840 that is coaxially supportedwithin the cutter housing 800 for selective axial travel therein. Theanvil shaft assembly 840 may comprise a distal end post 842 thatprotrudes from a portion of the firing shaft firing shaft 750. Thedistal end post 842 supports a distal anvil connector 850 therein thatthat protrudes distally from the distal end post 842. The anvil shaftassembly 840 has a proximal end portion that interfaces with anadjustment knob 760 that is rotatably supported on the handle assembly712 as was discussed above with respect to other non-limitingembodiments. The circular stapler 700 further includes an anvil 170 asshown in FIG. 32.

One exemplary method of using the circular stapler 700 will now bedescribed. To commence the procedure, the surgeon inserts the elongatedshaft 714 through the patient's anus 199 into a proximal portion 201 ofthe colon 200. Thereafter, the surgeon may extend the detection members781 as illustrated in FIGS. 36 and 37 to “fine tune” the positioning ofthe stapler head 720. This may be accomplished by rotating the detectionknob 791 in the appropriate direction. As the bumpers 785 are forcedradially into the wall of colon portion 201, they create identifiablebumps or deflections 203 or irregular areas that protrude outward andprovide means for the surgeon to visually observe where the stapler head720 is located. Such identifiable features are distinct from the actualanatomy of the colon wall. The substantially blunted or rounded bumpersdo not penetrate or damage the colon wall. Such bumps 203 allow thesurgeon to position the stapler head 720 relative to the tumor ordiseased portion 202 of the colon. If one or more of the bumpers 785comprise lights, the surgeon may view the lights through the colon wallas indicated in FIG. 37.

Once the surgeon has located the stapler head 720 in the desiredlocation within the proximal portion 201 of the colon 200, the surgeonmay then retract the detection members 781 into the hook and detectionhousing 770 by rotating the detection knob 791 in a direction that isopposite to the direction in which the detection members 781 were causedto be extended. The acquisition hook members 780 may then be extended topierce through and acquire the adjacent portions of the proximal colonwall 201. In alternative embodiments, however, the surgeon may elect tomaintain the detection members 781 in their extended positions as shownin FIG. 37. In doing so, the detection members 781 may produce some“hoop stress” in the colon wall which may assist in the acquisition andpiercing of the proximal colon wall 201 by the acquisition hook members780.

To cause the acquisition hooks 780 to engage and penetrate the proximalcolon portion 201, the surgeon advances the hook and detection housing770 distally by moving the hook switch 790 in the distal direction(arrow 792 in FIG. 32). Movement of the hook and detection housing 770in the distal direction causes the acquisition hook members 780 to moveaxially out of their respective hook lumens 772. As the distal ends ofthe acquisition hook members 780 exit their respective hook lumens 772,they move radially outward to engage and pierce through adjacentportions of the proximal colon wall 201. See FIG. 37. Once the hookmembers 780 have pierced and engaged the adjacent portions of theproximal colon wall 201, the surgeon moves the hook switch 790 in theproximal direction (represented by arrow 794 in FIG. 32) to retract theacquisition hook members 780 into their respective hook lumens 772 aswell as retract the hook and detection housing 770 back to its startingposition. The barbs 784 on the distal ends of the acquisition hookmembers 780 draw the engaged portions of the proximal colon wall 201into a position similar to the position illustrated in FIG. 9. Once theportions of the proximal colon portion 201 have been drawn into theposition illustrated in FIG. 9, the surgeon may then complete theprocedure by performing the same actions described above with respect tothe circular stapler 10.

FIG. 38 illustrates another circular stapler 900 according to variousnon-limiting embodiments of the invention. The circular stapler 900generally includes a handle assembly 912 that has an elongated shaft 914protruding therefrom. The elongated shaft 914 may define a central axisA-A. As can be seen in FIG. 38, the elongate shaft 914 includes a rigidouter sheath 916 that has a stapler head 920 located at the distal end917 thereof. In various non-limiting embodiments, the stapler head 920is configured to operably support a circular staple cartridge 930therein. Such circular staple cartridges 930 are known in the art andmay generally support one, two, or more than two circumferentiallyspaced and staggered rows of staples 36 therein as was describedhereinabove. A conventional annular knife 940 is coaxially and movablysupported within the stapler head 920. See FIG. 39.

The circular stapler 900 further includes a firing shaft 950 that issupported within the rigid outer sheath 916 for selective axial traveltherein. See FIG. 39. A distal end portion 952 of the firing shaft 950has an outer staple driver portion 954 thereon for engagement with eachof the staples 36 in the outer row 32 of staples 36 in the staplecartridge 930. In addition, the distal end portion 952 of the firingshaft 950 has an inner staple driver portion 956 configured forengagement with each of the staples 36 in the inner row 34 of staples 36within the staple cartridge 930. As can also be seen in FIG. 39, forexample, the distal end portion 952 of the firing shaft assembly 950further has a flanged portion 958 that is configured to engage theannular knife 940. Thus, as will be discussed in further detail below,axial advancement of the firing shaft 950 in a distal direction “DD”,will cause the staples 36 to be driven out of the staple cartridge 930as well as the annular knife 940 to advanced distally.

In various non-limiting embodiments, the firing shaft 950 may interfacewith a firing trigger 960 that is operably coupled to the handleassembly 912. See FIG. 38. As can be seen in FIG. 38, the firing trigger960 may be pivotally coupled to the handle assembly 912 such that whenthe firing trigger 960 is pivoted toward the handle assembly 912, thefiring shaft 950 is moved in the distal direction DD. As was discussedabove, such firing trigger arrangements are known in the art andtherefore will not be discussed in detail herein.

As shown in FIG. 39, various non-limiting embodiments may also include ahollow deployment shaft 970 that is coaxially supported within a hollowtissue acquisition shaft 980. The proximal end of the deployment shaft970 is operably attached to an arm deployment knob 910 that is rotatablysupported on the handle assembly 912 in the various manners describedabove. Thus, rotation of the arm deployment knob 910 on the handleassembly 912 will result in the rotation of the deployment shaft 970about the central axis A-A. More specifically and with reference to FIG.40, in various embodiments, a distal end 972 of the deployment shaft 970protrudes through a hole 982 in the tissue acquisition shaft 980 and hasa drive gear 974 attached thereto. A distal end 984 of the tissueacquisition shaft 980 is configured to operably support at least onetissue acquisition member or arm 1000 thereon. Two or more tissue arms1000 are preferable. In the non-limiting embodiment depicted in FIG. 40,a total of four tissue arms 1000 are pivotally pinned to the distal end984 of the tissue acquisition shaft 980 by corresponding pins 986.

Each tissue arm 1000 may have a body portion 1002 that may be fabricatedfrom, for example, stainless steel (300 or 400 series), titanium,titanium-steel composite, ceramic, etc. and have a driven gear 1004attached thereto or formed thereon. The driven gear 1004 of each tissuearm 1000 is movably supported within a corresponding arm cavity 988formed in the distal end 984 of the tissue acquisition shaft 980. Eachdriven gear 1004 is in meshing engagement with the drive gear 974 on thedeployment shaft 970. Thus, rotation of the deployment shaft 970 willresult in the pivotal deployment of the tissue arms 1000 from theretracted position depicted in FIG. 41 to the deployed position depictedin FIG. 42. In various embodiments, the body portion 1002 of each tissuearm 1000 may further have a tissue piercing tip 1006 formed thereon orotherwise attached thereto.

In various embodiments, a knife shaft 1010 is coaxially received withinthe deployment shaft 970 and interfaces with a knife knob 1020 (FIG. 38)rotatably supported on the handle assembly 912 such that rotation of theknife knob 1020 results in the rotation of the knife shaft 1010. Theknife shaft 1010 further has a distal end 1012 that protrudes out of thedistal ends 972, 984 of the deployment shaft 970 and the tissueacquisition shaft 980, respectively. See FIG. 40. A knife 1030 may beremovably attached to the distal end 1012 of the knife shaft 1010 by,for example, pins 1032 or other suitable fasteners. In variousembodiments, the knife 1030 may be substantially planar and havediametrically opposed tissue-piercing points 1031, 1033 formed thereonas shown in FIG. 40.

As can also be seen in FIG. 39, various non-limiting embodiments mayfurther include an anvil shaft assembly 440 that includes a distal endpost 442 that protrudes from a portion of the firing shaft 950 thatcoaxially extends within the deployment shaft 970 for selective axialtravel therein. The distal end post 442 supports a distal anvilconnector 450 therein that is coupled to an adjustment knob 460 that isrotatably supported on the handle assembly 312 in the various mannersdiscussed above.

The circular stapler 900 further includes an anvil 470 as shown in FIG.39. In various non-limiting embodiments, the anvil 470 includes an anvilbase 471 that has a series of staple forming pockets 472 therein. Theanvil base 471 may further define a shear edge 473 for facilitating theshearing of tissue by the annular knife 940. The anvil 470 may furtherinclude an anvil shaft 474 that is removably attachable to the distalanvil connector 450. In particular, a coupling stem 476 protrudes fromthe proximal end 475 of the anvil shaft 474 and is sized to be slidablyreceived in a passage 452 in the anvil shaft assembly 450. The anvil 470may further have an anvil cap 478 thereon that serves to define a tissuecavity 479 therein as illustrated in FIG. 39.

One exemplary method of using the circular stapler 900 will be describedwith reference to FIGS. 39 and 43-51. Turning first to FIG. 39, thestapler head 920 is inserted into a tubular organ such as the colon 200through the patient's anus 199. The stapler head 920 is located in theproximal portion 201 of the colon 200 that is adjacent to a diseasedportion 202. Thereafter, the tissue arms 1000 are radially deployed byrotating the arm deployment knob 910 in a first direction (representedby arrow 911 in FIG. 38) which also rotates the deployment shaft 970.Rotation of the deployment shaft 970 in the first direction also rotatesthe drive gear 974 which is in meshing engagement with the driven gearportions 1004 of each tissue arm 1000. Thus, rotation of the drive gear974 in the first direction causes the tissue arms 1000 to be radiallydeployed. As the tissue arms 1000 are radially deployed, the tissuepiercing tips 1006 thereof pierce through proximal portion 201 of thecolon 200. See FIGS. 44 and 45. The surgeon may then rotate the armdeployment knob 910 in the opposite or second direction (represented byarrow 913 in FIG. 38) to retract the tissue arms 1000 into theirretracted position (FIG. 20). As the tissue arms 1000 are retracted, thepierced proximal portion 201 of the colon 200 is carried by the tissuearms 1000 such that the portion 201 is gathered between the tissue arms1000 and the arm shaft 980 in a confronting position adjacent the staplecartridge 930. Thereafter, the surgeon may rotate the knife knob 1020 tocause the knife 1030 to rotate and sever the diseased portion 202 of thecolon 200 from the proximal portion of the colon 201. The diseasedportion 202 may be transected from a distal portion 208 of the colonusing a conventional laparoscopic tissue severing instrument (not shown)inserted through a trocar sleeve (not shown) positioned in the abdominalcavity 601. After the diseased portion 202 has been cut away from theproximal portion 201 of the colon 200 and the distal portion 208, thediseased portion 202 may be removed through the trocar sleeve with aconventional grasping instrument 600. See FIG. 48.

The surgeon may then orient the anvil 470 within the distal portion 208of the colon 200 such that the anvil shaft coupling stem 476 of theanvil shaft 474 protrudes out of the distal portion 208 of the colon 200as shown in FIG. 49. The surgeon may then tie the end of the distalcolon portion 208 around the anvil shaft 474 using what is known in theart as a “purse string suture” 220. Once the distal colon portion 208has been sutured around the anvil shaft, 474, the coupling stem 476 ofthe anvil shaft 474 is inserted into the passage 452 in the anvil shaftassembly 450. The coupling stem 476 may be sized relative to the passage452 to establish a frictional fit therebetween to retain the couplingstem 476 therein, yet permit the coupling stem 476 to be removedtherefrom at a later time. See FIG. 49.

The surgeon then draws the anvil 470 toward the stapler head 920 (in theproximal direction “PD”) by rotating the anvil control knob 460 in theappropriate direction until portions 205, 210 of the colon 200 areclamped between the anvil 470 and the staple cartridge 930 as shown inFIG. 50. Thereafter, the surgeon actuates the firing trigger 960 toaxially advance the firing shaft 950 in the distal direction “DD”. Asfiring shaft 950 is advanced distally, the staple driver portion 954serves to drive the staples 36 through the portions 205, 210 of colon200 into the anvil forming pockets 472 in the anvil base 471. The firingshaft 950 also advances the annular knife 940 to sever the colonportions 201, 207 from colon portions 205, 210 respectively. The surgeonmay then move the anvil 470 in the distal direction “DD” to release thestapled colon portions 205, 210 from between the anvil 470 and thestapler head 920. The instrument 900 may then be removed from the colon200. See FIG. 51. The severed portion 207 is captured in the anvilcavity 479 and the severed portion 201 is retained between the tissuearms 1000 and the arm shaft 980. Thus, the cut portions 201, 207 of thecolon 200 are removed from the repaired colon when the instrument 900 iswithdrawn therefrom.

As the surgeon performs the above described procedures or other relatedprocedures in that region of the body, care has to be taken to avoidinadvertently damaging adjacent soft tissues and bone structures. FIGS.52 and 53 illustrate some of the adjacent tissue and bone structuresthat are adjacent to the colon 200. In FIG. 52, the peritoneum 1100 hasbeen dissected to illustrate, for example, the sphincter ani 1101, thesacrotuberous ligament 1102, the ischtal tuberosity 1104, theischiorectal fossa 1106, levator ani 1108, and the third sacral vertebra1110. FIG. 53 further illustrates the para rectal fossa 1112, thesacrogenital fold 1114, the ureter 1116, the ductus deferens 1118, thebladder 1120, the paravesical fossa 1122, and the transvesical folds1124. The surgeon must also be careful not to damage the muscles,nerves, vessels and arteries along the inter wall of the peritoneum 1100when accessing the portion of the colon 200 to be transected.

FIGS. 54-57 illustrate use of a protective sheath 1200 of a non-limitingembodiment of the present invention. In various embodiments, the sheath1200 may be fabricated from, for example, Kevlar, polyethylene, Nylon,etc. and be stressed in a fashion that naturally makes it want to coil.See FIG. 55. In various embodiments, measurement or reference indicia1202 may be provided on the sheath 1200 to assist the surgeon inlocating the operable portion of a surgical instrument (e.g., thestapler head of a circular stapler) and to prevent accidental damage ofadjacent nerves, vessels and tissue. In still other embodiments, thesheath 1200 may be fabricated from a magnetic sensitive film that wouldenable it to be magnetically attracted to the operable portion of theinstrument to protect the adjacent anatomical structures and tissuesfrom, for example, portions of the instrument that might damage adjacenttissues, muscles, bones, nerves, etc. if the instrument portions werebrought into inadvertent contact therewith. In further alternativeembodiments, the sheath 1200 may have a magnetic interaction ring orportion that is attracted to the stapler head. Thus, at least a portionof the sheath 1200 may be magnetic or otherwise have magnetic materialattached thereto.

The sheath 1200 may be installed through a cannula 1252 of aconventional trocar 1250 that is laparoscopically inserted through theabdominal wall into the abdominal cavity as shown in FIG. 54. Aconventional laparoscopic grasping instrument 600 may be used as shownin FIGS. 54 and 55 to remove the sheath 1200 from the trocar cannula1252. Thereafter, the surgeon may wrap the unrolled sheath 1200 aroundthe colon 200 using conventional grasping devices 600 as shown in FIG.56. FIG. 57 illustrates the sheath 1200 after it has been wrapped aroundthe colon 200 and prior to commencing insertion of the circular staplinginstrument into the colon. The natural coiling nature of the sheathserves to retain it in a coiled orientation about the colon 200.

The sheath 1200 of the present invention may be effectively employed toprotect adjacent tissues and organs during use of any of theabove-mentioned embodiments. See, for example, FIGS. 5-16, 23-31, 36,39, and 43-51, wherein the sheath 1200 has been installed around thecolon 200 in the above-described manner. In addition, the non-limitingembodiments of the sheath 1200 may be effectively used in connectionwith conventional circular stapling devices and the like withoutdeparting from the spirit and scope of the present invention. For thoseinstrument embodiments that employ lights on the detection members orthe like, the sheath 1200 may be fabricated from, for example, lightsensitive film that would cause portions of the sheath 1200 to changecolor in those areas adjacent to the lighted detection members. See Forexample, the non-limiting embodiment depicted in FIG. 36.

The various embodiments of the present invention represent a vastimprovement over prior circular staple arrangements and proceduresassociated therewith. While several embodiments of the invention havebeen described, it should be apparent, however, that variousmodifications, alterations and adaptations to those embodiments mayoccur to persons skilled in the art with the attainment of some or allof the advantages of the invention. For example, according to variousembodiments, a single component may be replaced by multiple components,and multiple components may be replaced by a single component, toperform a given function or functions. This application is thereforeintended to cover all such modifications, alterations and adaptationswithout departing from the scope and spirit of the disclosed inventionas defined by the appended claims.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

The invention which is intended to be protected is not to be construedas limited to the particular embodiments disclosed. The embodiments aretherefore to be regarded as illustrative rather than restrictive.Variations and changes may be made by others without departing from thespirit of the present invention. Accordingly, it is expressly intendedthat all such equivalents, variations and changes which fall within thespirit and scope of the present invention as defined in the claims beembraced thereby.

What is claimed is:
 1. A surgical instrument, comprising: an elongateshaft assembly operably supporting a circular surgical staple cartridgein a distal end thereof; a plurality of arcuate tissue acquisitionmembers pivotally attached to said elongate shaft assembly andconfigured to be selectively radially deployable from a first positionwherein said plurality of arcuate tissue acquisition members cooperateto form a continuous ring defining a continuous outer ring diameter anda second deployed position wherein each said arcuate tissue acquisitionmember extends radially outward from said elongate shaft assembly; meansfor selectively deploying said plurality of arcuate tissue acquisitionmembers between said first position and said second deployed position; atissue cutting member comprising two diametrically opposed ends forminga plurality of tissue cutting edges, said tissue cutting membercomprising a tissue cutting diameter that does not exceed saidcontinuous outer ring diameter formed by said plurality of arcuatetissue acquisition members when said plurality of arcuate tissueacquisition members are in said first position; and means forselectively rotating said tissue cutting member relative to saidplurality of arcuate tissue acquisition members.
 2. The surgicalinstrument of claim 1, wherein said plurality of arcuate tissueacquisition members are distal to said circular surgical staplecartridge.
 3. The surgical instrument of claim 1, wherein saiddiametrically opposed ends of said tissue cutting member are each formedby at least one corresponding said tissue cutting edge that terminatesin a tissue piercing point.
 4. The surgical instrument of claim 3,wherein said at least one corresponding tissue cutting edge comprises: afirst tissue cutting edge on one side of said tissue cutting member; anda second tissue cutting edge on another side of said tissue cuttingmember and parallel to said first tissue cutting edge.
 5. The surgicalinstrument of claim 3, wherein said continuous outer ring diameter isless than a diameter of said circular surgical staple cartridge.
 6. Thesurgical instrument of claim 3, wherein said continuous outer ringdiameter is less than a diameter of said circular surgical staplecartridge.
 7. The surgical instrument of claim 1, wherein said pluralityof arcuate tissue acquisition members are deployed from said firstposition to said second deployed position by applying a rotarydeployment motion to said tissue acquisition members with said means forselectively deploying said plurality of arcuate tissue acquisitionmembers.
 8. The surgical instrument of claim 7, wherein said means forselectively deploying said plurality of arcuate tissue acquisitionmembers between said first position and said second deployed positioncomprises a rotary drive gear that is in meshing engagement with arotary driven gear on each of said arcuate tissue acquisition members.9. The surgical instrument of claim 8, wherein said rotary drive gear isactuated by a rotary drive shaft that protrudes through said circularsurgical staple cartridge.
 10. The surgical instrument of claim 9,wherein said surgical instrument further comprises an anvil shaftassembly supported for selective axial travel relative to said rotarydrive shaft and configured to be operably coupled to an anvil supportedin confronting relationship relative to said circular surgical staplecartridge.
 11. The surgical instrument of claim 8, wherein each saidtissue acquisition member further comprises an arcuate body comprising afirst end and a second end, and wherein said first end comprises saidrotary driven gear and said second end comprises a tissue piercingacquisition tip.
 12. The surgical instrument of claim 11, wherein eachsaid tissue piercing acquisition tip is formed at an end of an arcuatesurface formed on said second end of said arcuate body.
 13. The surgicalinstrument of claim 1, wherein each said tissue acquisition membercomprises a tissue piercing acquisition tip formed thereon.
 14. Acircular surgical fastening instrument, comprising: an elongate shaftassembly operably supporting a circular surgical fastener cartridge in adistal end thereof; a plurality of arcuate tissue acquisition memberspivotally attached to said elongate shaft assembly and configured to beselectively radially deployable from a first position wherein saidplurality of arcuate tissue acquisition members cooperate to form acontinuous ring defining a continuous outer ring diameter and a seconddeployed position wherein each said arcuate tissue acquisition memberextends radially outward from said elongate shaft assembly; a rotarydrive shaft protruding through said circular surgical fastener cartridgeand operably interfacing with said plurality of arcuate tissueacquisition members for applying rotary deployment motions thereto; atissue cutting member comprising two diametrically opposed ends forminga plurality of tissue cutting edges, said tissue cutting membercomprising a tissue cutting diameter that does not exceed saidcontinuous outer ring diameter formed by said plurality of arcuatetissue acquisition members when said plurality of arcuate tissueacquisition members are in said first position; an anvil shaft assemblysupported for selective axial travel relative to said rotary driveshaft; an anvil configured to be removably attached to a distal end ofsaid anvil shaft assembly such that when attached thereto, said anvil isin confronting relationship relative to said circular surgical fastenercartridge; and means for selectively deploying fasteners from saidcircular surgical fastener cartridge.
 15. The circular surgicalfastening instrument of claim 14, wherein said means for deployingfasteners comprises an axially movable fastener driver shaft configuredto eject said fasteners from said circular surgical fastener cartridge.16. The circular surgical fastening instrument of claim 15, furthercomprising a handle assembly coupled to said elongate shaft assembly,said handle assembly comprising a firing trigger configured to applyaxial firing motions to said axially movable fastener drive shaft. 17.The circular surgical fastening instrument of claim 14, wherein saidplurality of arcuate tissue acquisition members are distal to saidcircular surgical fastener cartridge.
 18. The circular surgicalfastening instrument of claim 14, wherein said diametrically opposedends of said tissue cutting member are each formed by at least onecorresponding said tissue cutting edge that terminates in a tissuepiercing point.
 19. The circular surgical fastening instrument of claim18, wherein said at least one corresponding tissue cutting edgecomprises: a first tissue cutting edge on one side of said tissuecutting member; and a second tissue cutting edge on another side of saidtissue cutting member and parallel to said first tissue cutting edge.